| Device Type ID | 2578 |
| Device Name | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Regulation Description | Intravascular Catheter. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.5200 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FOZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 2578 |
| Device | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Product Code | FOZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Intravascular Catheter. |
| CFR Regulation Number | 880.5200 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
B. BRAUN MEDICAL INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
B. BRAUN MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BD | ||
SUBSTANTIALLY EQUIVALENT | 9 | |
BECTON, DICKINSON & CO. | ||
SUBSTANTIALLY EQUIVALENT | 9 | |
BECTON, DICKINSON AND COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
C.R. BARD, INC. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
DELTA MED SPA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HEALTH LINE INTERNATIONAL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KOFU FACTORY OF TERUMO CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDSOURCE INTERNATIONAL, LLC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MERIT MEDICAL SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NAVILYST MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
NIPRO CORP | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
NIPRO CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SMITHS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SMITHS GROUP PLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TANGENT MEDICAL TECHNOLOGIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TERUMO (PHILIPPINES) CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TERUMO CARDIOVASCULAR SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TERUMO CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TOGO MEDIKIT CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
VASCULAR PATHWAYS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
VYGON | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VYGON CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Kinked | 455 |
Break | 319 |
Catheter | 236 |
Physical Resistance | 219 |
Unraveled Material | 217 |
Leak / Splash | 199 |
Difficult To Advance | 134 |
Crack | 129 |
Material Separation | 127 |
Dull, Blunt | 126 |
Needle | 119 |
Fluid Leak | 102 |
Material Deformation | 99 |
Activation, Positioning Or Separation Problem | 88 |
Adverse Event Without Identified Device Or Use Problem | 69 |
Fracture | 67 |
Safety Interlock | 53 |
Product Quality Problem | 52 |
Occlusion Within Device | 50 |
Positioning Failure | 49 |
Sticking | 48 |
Use Of Device Problem | 46 |
Material Integrity Problem | 46 |
Difficult To Remove | 45 |
Material Fragmentation | 45 |
Bent | 44 |
Detachment Of Device Component | 42 |
Difficult To Position | 40 |
Difficult To Insert | 39 |
Hub | 38 |
Difficult Or Delayed Positioning | 38 |
Detachment Of Device Or Device Component | 36 |
Obstruction Of Flow | 34 |
Structural Problem | 33 |
Device Operates Differently Than Expected | 33 |
Stretched | 28 |
Split | 27 |
Material Frayed | 27 |
Protective Measures Problem | 25 |
Device Damaged Prior To Use | 24 |
Migration Or Expulsion Of Device | 24 |
Failure To Advance | 23 |
Gas Leak | 22 |
Hole In Material | 21 |
Material Rupture | 20 |
Label | 18 |
Infusion Or Flow Problem | 15 |
Physical Resistance / Sticking | 15 |
Air Leak | 14 |
Device Issue | 14 |
Patient-Device Incompatibility | 14 |
Partial Blockage | 13 |
Disconnection | 12 |
Manufacturing, Packaging Or Shipping Problem | 12 |
Difficult Or Delayed Separation | 12 |
Insufficient Information | 11 |
Fitting Problem | 11 |
Appropriate Term/Code Not Available | 10 |
Component Missing | 9 |
Contamination / Decontamination Problem | 9 |
Connection Problem | 9 |
Material Twisted / Bent | 9 |
Improper Or Incorrect Procedure Or Method | 9 |
Defective Component | 9 |
Loose Or Intermittent Connection | 9 |
Torn Material | 8 |
Cannula | 8 |
Device Dislodged Or Dislocated | 8 |
Deformation Due To Compressive Stress | 7 |
Mechanical Problem | 7 |
Failure To Disconnect | 7 |
Device Markings / Labelling Problem | 6 |
Device Or Device Fragments Location Unknown | 6 |
Device Contamination With Chemical Or Other Material | 6 |
Delamination | 6 |
Material Puncture / Hole | 6 |
Guidewire | 6 |
Difficult To Flush | 5 |
Device Remains Activated | 5 |
Device Handling Problem | 5 |
Failure To Align | 5 |
Cut In Material | 4 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 4 |
Difficult Or Delayed Activation | 4 |
Insufficient Flow Or Under Infusion | 4 |
Entrapment Of Device | 4 |
Separation Failure | 4 |
Material Too Rigid Or Stiff | 4 |
Residue After Decontamination | 4 |
Material Split, Cut Or Torn | 4 |
Uncoiled | 4 |
Burst Container Or Vessel | 3 |
Device Operational Issue | 3 |
Migration | 3 |
Tube | 3 |
Complete Blockage | 3 |
Folded | 3 |
Component Or Accessory Incompatibility | 3 |
Expulsion | 3 |
Connector | 3 |
| Total Device Problems | 4159 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Angiodynamics Inc. (Navilyst Medical Inc.) | II | Jun-14-2018 |
| 2 | Arrow International Inc | II | Nov-14-2018 |
| 3 | Arrow International Inc | II | Oct-26-2018 |
| 4 | Arrow International Inc | II | Aug-22-2018 |
| 5 | Arrow International Inc | II | Aug-14-2018 |
| 6 | Arrow International Inc | II | May-30-2018 |
| 7 | Arrow International Inc | II | Apr-10-2018 |
| 8 | Arrow International Inc | II | Mar-21-2018 |
| 9 | Arrow International Inc | II | Mar-14-2018 |
| 10 | Arrow International Inc | II | Mar-14-2018 |
| 11 | Arrow International Inc | II | Mar-05-2018 |
| 12 | Arrow International Inc | II | Feb-20-2018 |
| 13 | Arrow International Inc | II | Jun-12-2017 |
| 14 | Arrow International Inc | II | Jun-06-2017 |
| 15 | Arrow International Inc | II | Apr-10-2017 |
| 16 | Arrow International Inc | II | Jul-06-2016 |
| 17 | Arrow International Inc | II | Sep-30-2015 |
| 18 | Arrow International Inc | II | Feb-10-2015 |
| 19 | Arrow International Inc | II | Jan-22-2015 |
| 20 | Arrow International Inc | II | May-19-2014 |
| 21 | Arrow International Inc | II | Apr-24-2014 |
| 22 | Bard Access Systems | II | Mar-13-2015 |
| 23 | Bard Access Systems | II | Jan-23-2014 |
| 24 | Becton Dickinson & Company | II | Nov-04-2018 |
| 25 | Becton Dickinson & Company | II | May-18-2016 |
| 26 | Becton Dickinson & Company | II | Dec-12-2014 |
| 27 | Centurion Medical Products Corporation | I | Dec-02-2016 |
| 28 | Cook Inc. | II | Feb-15-2018 |
| 29 | Cook Inc. | II | Dec-12-2016 |
| 30 | Nipro Medical Corporation | III | Jan-06-2016 |
| 31 | Nipro Medical Corporation | II | Jun-19-2014 |
| 32 | Smiths Medical ASD Inc. | II | Dec-19-2016 |
| 33 | Terumo Medical Corporation | II | May-01-2017 |
| 34 | Vygon Corporation | II | Oct-22-2014 |